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Guidelines for Stem cell science and Clinical translation


줄기세포연구 및 임상중개에 관한 지침


ISSCR(INTERNATIONAL SOCIETY FOR STEM CELL RESEARCH)


- 가이드라인 바로가기 : http://www.isscr.org/docs/default-source/guidelines/isscr-guidelines-for-stem-cell-science-and-clinical-translation.pdf?sfvrsn=2

- 첨부파일 : 하단에 첨부를 눌러주세요   2016_isscr-guidelines-for-stem-cell-science-and-clinical-translation.pdf

- 참고 : http://www.nibp.kr/xe/news2/62699



TABLE OF CONTENTS



Preface.......................................................................................................2
Dedication.................................................................................................2
1. Fundamental Ethical Principles..........................................................4
2. Laborator y-based Human Embr yonic Stem Cell Research,
Embr yo Research, and Related Research Activities......................5
2.1 Review Processes..........................................................................................................5
2.2 Procurement of Biomaterials......................................................................................8
2.3 Derivation, Banking and Distribution of
Human Pluripotent Stem Cell Lines....................................................................... 11
2.4 Mechanisms for Enforcement.................................................................................. 12
3. Clinical Translation of Stem Cells.................................................. 13
3.1 Cell Processing and Manufacture............................................................................ 13
3.1.1 Sourcing Material............................................................................................................ 14
3.1.2 Manufacture..................................................................................................................... 14
3.2 Preclinical Studies ..................................................................................................... 15
3.2.1 General Considerations................................................................................................. 16
3.2.2 Safety Studies.................................................................................................................. 16
3.2.3 Efficacy Studies .............................................................................................................. 18
3.2.4 Transparency and Publication....................................................................................... 18
3.3 Clinical Research........................................................................................................ 19
3.3.1 Over sight.......................................................................................................................... 19
3.3.2 Standards for Clinical Research Conduct.................................................................. 20
3.3.3 Issues Par ticular to Ear ly Phase Trials......................................................................... 22
3.3.4 Issues Par ticular to Late Phase Trials.......................................................................... 23
3.3.5 Research Subject Follow-up and Trial Monitoring .................................................. 23
3.3.7 Transparency and Repor ting of Research Results.................................................... 24
3.4 Stem Cell-based Medical Innovation...................................................................... 24
3.5 Clinical Application.................................................................................................... 26
3.5.1 Regulator y Approval...................................................................................................... 26
3.5.2 Access and Economics................................................................................................... 27
4. Communications............................................................................... 28
5. Standards in Stem Cell Research................................................... 29
Acknowledgements............................................................................... 30
ISSCR Guidelines Updates Task Force.............................................. 30
Appendices.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Glossar y.................................................................................................. 32
References.............................................................................................. 35








List of Articles
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공지 [보건복지부 공고 제2019 - 55호] 제1차 사전연명의료의향서 등록기관 지정 신청 안내 newfile 2019-01-16 4
공지 [(재)국가생명윤리정책원 공고 2019-1호] 사전연명의료의향서 등록기관 운영 지원 사업 공고 file 2019-01-09 50
공지 [학술지 발간] 『생명, 윤리와 정책』 제2권 제2호 발간 안내 file 2018-10-31 1512
공지 사전연명의료의향서 작성 가능 기관 안내 file 2018-10-30 323
공지 선언 생명존중을 위한 선언문_일어 (生命尊重のための宣言文) file 2017-07-26 221
공지 선언 생명존중을 위한 선언문_영문 (Declaration on Respect for Life) file 2016-08-01 489
공지 선언 국가생명윤리심의위원회 생명존중을 위한 선언문 file 2016-05-17 947
65 국내 2018 모성보호와 일가정 양립 지원 업무편람 / 고용노동부 2018-06-22 153
64 국외 미국 국립과학원 인간배아줄기세포 연구지침(Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research) file 2017-07-12 318
63 국외 NCI best practices for biospecimen resources(2016) file 2017-07-12 262
62 국외 OECD Guidelines for Quality Assurance in Genetic Testing(2007) 2017-07-12 261
61 국외 International Compilation of Human Research Standards(2017) /HHS.gov file 2017-07-07 288
60 국외 의료기기에 관한 지침( Directive 93/75/CEE du Conseil relative aux dispositifs medicaux) 2017-04-07 187
59 국내 2017 실무자를 위한 비영리·공익 법인 관리·감독 업무 편람 file 2017-03-27 2558
» 국외 Guidelines for Stem cell science and Clinical translation file 2016-05-16 990
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56 국내 2016 장기·인체조직 등록기관 업무가이드 file 2016-04-25 393
55 국외 나고야의정서(Nagoya Protocol, ABS) file 2016-04-07 1223
54 국내 생물자원센터를 위한 OECD 모범운영지침 2016-04-07 226
53 국내 종양성 질환자원 임상정보수집 표준화를 위한 가이드라인(2015) file 2016-04-06 245
52 국내 2015 인체유래물은행 표준운영지침 file 2016-04-06 1296
51 국외 Guide on the decision-making process regarding medical treatment in end-of-life situations 2016-03-29 291
50 국외 Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, with Revisions 2016-02-15 220
49 선언 국제의사 윤리헌장 (International Code of Medical Ethics ) 2015-09-25 735